Samsung BioLogics says 180,000L plant is completed but not validated

By Dan Stanton

- Last updated on GMT

Image c/o Samsung BioLogics
Image c/o Samsung BioLogics

Related tags Samsung biologics

The Korean CDMO says construction of its third – and largest – biomanufacturing facility is complete with the validation process expected to take a year.

Samsung BioLogics has completed the $740m construction of its third facility at its site in Songdo, Incheon, the firm said today.

The site brings an additional 180,000L of stainless steel bioreactor capacity to the two operational plants on the site, and will, once validated, become the largest single bioproduction site in the world, overtaking Samsung BioLogics plant number two which boast 152,000L of capacity.

The CDMO did not respond to requests for comment when contacted by this publication, but stated on its website that “all the procedures related to mechanical building”​ were completed on November 30 and the plant will now undergo validation in a process expected to take a year.

The firm also rejected an apparent market rumour that a completion ceremony planned for the facility was cancelled ‘due to personnel problems,’ saying: “Since No.3 plant has to be validated for one year after mechanical completion, we did not schedule a separate building completion ceremony from the beginning.”

It added completion ceremonies did not take place following the construction of the 1st and 2nd plants at the site. The firm’s second plant was completed last year and recently received​ its first approval for the manufacture of a monoclonal antibody drug substance by the US Food and Drug Administration (FDA).

Once the third plant is validated, Samsung BioLogics will boast a total of 362,000L of mammalian cell culture capacity at the site, but in October​ CEO TH Kim said his firm is already considering constructing a fourth facility but this time outside of Korea.

“Considering the growing needs of our clients for tax reasons and geographic risk management, there is a lot of demand to build a plant out of Korea,”​ he told delegates at the CPhI Preconnect Congress in Frankfurt.

“We are seriously considering building a future plant out of Korea, hopefully in Europe or America, near to our clients.”

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